DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 2nd, 2026 has been entered.
Claim Status
Applicant’s amendments submitted on February 2nd, 2026 have been entered. Claims 20 and 66-84 are currently pending. Claims 1-19 and 21-65 have been cancelled. Claim 20 has been amended. Claims 81-84 have been newly added.
Response to Arguments
Applicant's arguments filed February 2nd, 2026 have been fully considered but they are not persuasive.
Regarding applicant’s arguments that neither Paul nor Roberts, alone or in combination, discloses or suggests this mid-height, rim-to-rim separable structure, examiner disagrees in that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the mating location of the top and bottom portions to be at the midpoint of the case height since this claimed position of the mating location being at the midpoint of the case height does not change the mating locations ability to seal the top portion to the bottom portion to create a chamber for placement of the catheter. Since applicant has not given any criticality to why the position of the mating location disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (see below rejection).
Regarding applicant’s argument that Roberts does not disclose the use of magnetic mating rims, examiner does not find this persuasive as Roberts is not relied upon to teach this feature, but this feature is rather seen to be disclosed by Paul (see rejection of claim 20 below).
Regarding applicant’s argument that Paul and Roberts cannot be combined as proposed without rendering Paul inoperable as the examiner’s rejection overlooks the functional necessity of Paul’s lid structure as the lid including a light is required for Paul’s operation, the examiner does not find this statement to be persuasive or evidenced by the disclosure of Paul. Firstly, Paul does not show or disclose any lights necessarily being on the lid of the device with Fig. 1A showing all of the lights present and supported by the bottom portion of the device and the disclosure of Paul does not state that any diodes are necessarily present in the lid as stated by the applicant in the statement “there must be a sterilizing light source in the lid to sterilize the portions of the medical device extending into the lid” and Paul further states that the walls are covered in UV reflective material ¶0055 and the UVLEDs are arranged on or along one or more of the walls and there is sufficient space to the opposing wall to allow reflection of the irradiation allowing irradiation of multiple surfaces which both states that the UVLED’s can be arranged in a number of different configurations which can involve “one or more of the walls” stating that every wall does not require a UVLED necessarily and that UV radiation is reflected which would allow for areas that are not provided with direct UV light radiation to be covered by the sterilizing effect of the LEDs.
However, to address the applicant’s argument that incorporation of UV lights into a lid that is capable of being fully removed would require substantial redesign of Paul to retain a light in the lid, with Roberts offering no teaching to overcome this incompatibility, the examiner disagrees in that Roberts teaches the ability to mount the ultraviolet source mounted in an upper lid which is closed over the device to be sterilized shining downward over the implements suggesting the implement is placed in a lower chamber (Col. 2 lines 65-68 and Col. 3 lines 1-4) as disclosed below as well as provides in Fig. 4 the showing of a compatible electronic switch that allows for energy transfer from a power source located in the lower portion of the device to a lid of the device which shows the ability to power lights (element 80) located in a lid that is fully removable. As such it is not found that Roberts offers no teaching to overcome this incompatibility and that Roberts specifically provides the structure necessary for one of ordinary skill in the art to have been apprised of how one would incorporate the light into the lid of the device as already taught by Roberts in (Col. 2 lines 65-68 and Col. 3 lines 1-4). As such the argument that to redesign Pauls lid in such a manner would require substantial redesign of Paul to retain a light in the lid, and that it would render Paul inoperable is not found to be persuasive as Roberts teaches the ability to place the sterilization lights in multiple positions on the device (Col. 2 lines 65-68 and Col. 3 lines 1-4) as well as how one would provide power to light sources on a removable lid of the device and as such provides the construction of how one of ordinary skill in the art would implement the different positions of the sterilizing light onto the upper lid of its devices.
Furthermore, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 20, 62-70, 74-81, and 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paul (U.S. Publication 2019/0328915) in view of Roberts (U.S. Patent No. 6,039,928).
Regarding claim 20, Paul discloses a reusable urinary catheter product (100 and 114), comprising: a case 100, having a case height (dimension defined by top wall 102 and bottom wall 103 between a top outer surface (outer surface of top wall 102) and a bottom outer surface (outer surface of bottom wall 103), having a top portion 138 and a bottom portion (portion of body below sealing gasket 112 that divides lid from bottom portion), the top portion and the bottom portion mating at a location between the top and bottom portion (point of sealing gasket 112 that divides lid from bottom portion) wherein the top portion and bottom portion have a closed configuration defining a reclosable compartment (¶0054 lid pivots about a hinge allowing the lid to open or close), and the top portion and bottom portion are separated from one another to open the reclosable compartment (¶0054 hinge separates the top and bottom portion and allows the top portion to separate from the bottom portion in order to open the compartment);
a magnetic material 119 extending on a rim of the top portion and a magnetic material 119 extending on a rim of the bottom portion (magnetic material 119 shown in Fig. 1A to magnetically connect together top portion and bottom portion and is present on the rim of the top and bottom portion that forms the joint between top and bottom portions indicated at element 112 that represents the seal between the top and bottom portions, the magnet being a three dimension object requires extension of the material in three dimensions one being in the dimension of the rim), wherein the magnetic material of the top portion and the magnetic material of the bottom portion mate to hold the case in the closed configuration (¶0054 magnetic lock 119 used to lock the apparatus during operation and storage).
a sterilizing light source 109 associated with the bottom portion (associated with interior chamber and can be seen to be placed along walls in Fig. 1A in the bottom portion and potentially the top as well ; and
a urinary catheter held by (placed inside and anchored by support 113) the bottom portion (placed inside interior chamber 106 made up by top and bottom portions, held by anchored support 113 that is located in bottom portion) by a catheter holder 113, wherein the urinary catheter may be removed and reattached to the catheter holder (medical device 114 positioned within interior ¶0050 and removal of device for use as shown in Fig. 2 which shows that the medical device is separate from the device and thus can be removed and reinserted according to users will, ¶0085 support structure fastens or secures medical device to allow consistent placement of the medical device within the interior, consistent placement dictates multiple placements and as such reattachments/removals).
Paul does not expressly disclose the mating locating being substantially at a midpoint of the case height, the top and bottom portion being completely separated from one another to open the reclosable compartment or the sterilizing light source and the urinary catheter being in separate portions, one placed in the top while the other is placed in the bottom.
However, Roberts, in the same field of endeavor of UV sterilizing devices, teaches a sterilization case (fig. 1) having a mating location (point at which top 10 and bottom 24 meet when hinges 32 and 34 are closed) being substantially at a midpoint of a case height (see illustrative diagram of Fig. 1 below), the use of either a hingedly or removably (Col. 6 lines 6-18 hingedly or removably) attached top or lid 82 and the ability to mount an ultraviolet light source in a number of different configurations (Col. 2 lies 50-60), one of which being the ultraviolet source mounted in an upper lid which is closed over the device to be sterilized shining downward over the implements suggesting the implement is placed in a lower chamber (Col. 2 lines 65-68 and Col. 3 lines 1-4).
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Illustrative diagram of Fig. 1 of Roberts.
Regarding the top and bottom portions mating at a midpoint of the case height, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the mating location of the top and bottom portions to be at the midpoint of the case height since this claimed position of the mating location being at the midpoint of the case height does not change the mating locations ability to seal the top portion to the bottom portion to create a chamber for placement of the catheter. Since applicant has not given any criticality to why the position of the mating location disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Furthermore, the device of Fig. 1 of Roberts shows a sterilization case (Fig. 1) having a mating location (point at which top 10 and bottom 24 meet when hinges 32 and 34 are closed) between top 10 and bottom 24 portions of the device substantially at a midpoint (point at which 32 and 34 are placed) of the case height (see illustrative diagram of Fig. 1 above) showing that arrangement of a mating location substantially at a midpoint of the height of a device was known in the art and one of ordinary skill would have had success performing the rearrangement of the mating location of Paul to the midpoint of the case height.
Regarding the lid attachment allowing for complete separation, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the hingedly attached lid of Paul for the removably attached lid of Roberts which results in the lid being completely separated from its corresponding bottom portion, since these elements perform the same function of attaching a top portion to a bottom portion such that they may form a contained volume that is openable and closable by the separation of the top portion away from the bottom portion. Simply substituting one openable attachment means for another would yield the predictable result of allowing a(n) containment case to have a top and bottom portion that are attached such as to be openable and closable. See MPEP 2143.
Furthermore, Roberts teaches that a hinged configuration is substitutable with a removably attached configuration as described in Col. 6 lines 6-17 stating that either a hinged configuration or a removably attached configuration is suitable for use, and Paul eludes to the possibility of alternate joints to the disclosed kinematic joint comprising two or more mated components containing one or more sealing components (¶0079 preferably a kinematic joint, such as a hinge is used…Alternatively, the interior is comprised of two or more mated components containing one or more sealing components), which shows that one of ordinary skill in the art would have had a reasonable expectation of success in substituting the hinge attached lid for the fully removably attached lid.
Regarding the positioning of the sterilizing light source, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the sterilizing light source and urinary catheter of Paul to be in the top portion and bottom portion respectively, as taught by Roberts, since this claimed position does not change the sterilizing light source’s ability to sterilize the urinary catheter placed within. Since applicant has not given any criticality to why the position of the light in respect to the urinary catheter disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Furthermore, the teachings of Roberts describe the positioning of the light source as a matter of design choice (Col. 2 line 50 to Col. 3 line 4) and as such would have been seen within the capability of one of ordinary skill in the art to have selected the positioning of the light source.
Furthermore, one of ordinary skill in the art would have been expected to have had reasonable success in positioning the sterilization lights in the removable lid of Paul in view of Roberts as Roberts discloses the ability to provide lights in removable lids in Fig. 4 element 80 showing the powering of said lights through the switch 86 that connects power from the base to the lid when the lid is placed on the base (Col. 6 lines 6-17).
Regarding claim 65, Paul in view of Roberts suggest the product of claim 20. Paul further discloses the other one of the top portion and the bottom portion (the other one is stipulated in the modification presented in claim 20 as the bottom portion, element 113 located in the bottom portion) including a catheter holder 113.
Regarding claim 66, Paul in view of Roberts suggest the product of claim 65. Paul further discloses the catheter holder 113 comprising brackets (bracket defined as a right-angled support attached to and projecting from a wall for holding an object, 113 is attached to wall of bottom portion and is used to support/hold catheter) for releasably attaching the catheter to other one of the top portion and the bottom portion (the other one is stipulated in the modification presented in claim 20 as the bottom portion, element 113 located in the bottom portion).
Regarding claim 67, Paul in view of Roberts suggest the product of claim 20. Paul further discloses the case including a barrier 302 covering the sterilizing light source 301, and light emitted from the light source passes through the barrier (¶0075 UV transparent window separates the interior chamber from the UVLED 301, UVLED irradiates into interior through 302 and 303).
Regarding claim 68, Paul in view of Roberts suggest the product of claim 67. Paul further discloses the barrier being transparent (¶0075 UV transparent).
Regarding claim 69, Paul in view of Roberts suggest the product of claim 67. Paul further discloses the barrier being made of a UV transparent material ¶0075 but does not expressly disclose the barrier being comprised of plastic or glass.
However, Paul teaches that the materials of plastic or glass are preferred when the quality of UV transparency/translucency is required by the object to made (¶0068 made from a material (e.g. plastic or glass) that is translucent to the radiation used for sterilization).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the barrier of Paul which is intended to be UV transparent, to have been made of glass or plastic as these materials are preferred when trying to form an object that is intended to be UV translucent/transparent as taught by Paul in ¶0068.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the UV transparent barrier of Paul out of plastic or glass, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 70, Paul in view of Roberts suggest the product of claim 20. Paul further discloses the sterilizing light source comprising one or more light emitting diodes (¶0075 UVLED, ultraviolet light emitting diode).
Regarding claim 74, Paul in view of Roberts suggest the product of claim 20. Paul further discloses including a fluid (Fig. 1A dark gray coloring indicates fluid) located within the reclosable compartment of the case (¶0062 fluid pumped into and out of the chamber).
Regarding claim 75, Paul in view of Roberts suggest the product of claim 74. Paul further discloses the fluid comprising a sterilization fluid (¶0062 mixture of water, hydrogen peroxide, and silver particles to enhance sterilization) and a hydration fluid (comprises water and therefore would be hydrating).
Regarding claim 76, Paul in view of Roberts suggest the product of claim 75. Paul further discloses the hydration fluid comprising silver (¶0062 silver particles).
Regarding claim 77, Paul in view of Roberts suggest the product of claim 76. Paul further discloses including a power source 110 for powering the sterilizing light source (¶0057 provides energy to the UVLEDs), wherein the power source comprises one battery (¶0057 rechargeable battery).
Regarding claim 78, Paul in view of Roberts suggest the product of claim 20. Paul further discloses wherein the case further includes reflective material that reflects sterilizing light (¶0053 one or more walls of the interior of the chamber are radiation reflective).
Regarding claim 79, Paul in view of Roberts suggest the product of claim 20. Paul further discloses wherein the sterilizing light source emits light for a selected period of time (¶0093 turned on for a set time).
Regarding claim 80, Paul in view of Roberts suggest the product of claim 20. Paul further discloses wherein the sterilizing light source is a UV light source (¶0075 UVLED).
Regarding claim 81, Paul discloses a reusable urinary catheter product (Fig. 1), comprising:
a case 100 comprising a body (bottom portion below sealing gasket 112 that divides lid from bottom portion) and a re-closable cap 138 that is removable from the body (element 207 shows removal from body);
a urinary catheter 114 having a catheter shaft (shaft of 114 seen in Fig. 1);
the case defining a first compartment 106 and a second compartment (Fig. 3 and ¶0075 area formed around LED 301 by UV transparent window 302 separating the LED from first compartment 106) , that are separated by a barrier 302 that allows the passage of light (¶0075 UV transparent window);
a urinary catheter (114, ¶0003 urinary catheter) located in the first compartment; and a sterilizing light source 301 located in the second compartment, wherein sterilizing light emitted from the light source passes through the barrier and into the second compartment (¶0075 light passes from 301 to barrier 302 and thus into second compartment and then further travels into the first compartment 106).
Paul does not expressly disclose the first compartment and the second compartment being concentric, the first compartment being substantially defined by the barrier, wherein the barrier surrounds the catheter shaft, and the second compartment being defined between the barrier and a wall of the body.
However, Roberts, in the same field of endeavor of UV sterilization cases, teaches a UV sterilization case (Fig. 2) comprising a first compartment and a second compartment (see below illustrative diagram of Fig. 2) that are separated by a barrier 54 that allows passage of light (Col. 5 lines 7-8 quartz materioa or any other material that is transparent to ultraviolet radiation…light from the sterilization lamps is directed into the inner cylinder) and is concentric with a first compartment thus making a second compartment on the other side of the barrier concentric with the first compartment (see illustrative diagram of Fig. 2 below) wherein the first compartment is substantially defined by the barrier (barrier defines separation of compartments 1 and 2), wherein the barrier surrounds the implement intended to be put inside the first compartment (Col. 5 lines 12-13 in which writing implements may be placed), and the second compartment being defined between the barrier and a wall of case 52; and a sterilizing light source (56, 58, 60, and 62) located in the second compartment, wherein the sterilizing light source extends along the wall of the body and is coextensive with the extension of first compartment (see fig. 2 extend from to bottom of cylinder).
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Illustrative diagram of Fig. 2 of Roberts (U.S. Patent No. 6,039,928).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sterilization lights and barrier of Paul that performs the functions of providing UV sterilizing light and separating the UV light source from the first chamber for the sterilization lights and barrier of Roberts since these elements perform the same function of providing UV sterilizing light and separating the UV light sources from an interior chamber. Simply substituting one UV sterilizing light and barrier means for another would yield the predictable result of allowing a(n) UV sterilizing light to be provided and separated from the implements that are intended to be sterilized. See MPEP 2143.
Regarding claim 84, Paul in view of Roberts suggest the product of claim 81. Paul further discloses including a fluid (Fig. 1A dark gray coloring indicates fluid) located within the reclosable compartment of the case (¶0062 fluid pumped into and out of the chamber).
Claim(s) 71-73 and 82-83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paul (U.S. Publication 2019/0328915) in view of Roberts (U.S. Patent No. 6,039,928) and Tsukada (U.S. Publication 2018/0015250).
Regarding claims 71-73 and 82-83, Paul in view of Roberts suggest the product of claim 20. Paul does not expressly disclose the urinary catheter having a titanium oxide coating (Claim 71), a lubricious hydrophilic coating (Claim 73 and 83), or a lubricious hydrophilic coating that includes the titanium dioxide (Claim 72 and 82).
However, Tsukada, in the same field of endeavor of urinary catheters, teaches a urinary catheter 50 having its surface coated with a lubricious hydrophilic material (¶0040 hydrophilic coating makes it easier to insert the balloon catheter suggesting that the hydrophilic material is inherently lubricious) including titanium dioxide (¶0041 also coated with photocatalytic material such as titanium dioxide) for the purpose of making the insertion of the catheter into the urethra of the user easy thus inhibiting urethra from being damaged ¶0040 and including a photocatalytic material such that when exposed to ultraviolet rays the surface of the catheter is disinfected ¶0041.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the urinary catheter of Paul to have included a lubricious hydrophilic material including titanium dioxide as taught by Tsukada for the purpose of making the insertion of the catheter into the urethra of the user easy thus inhibiting urethra from being damaged ¶0040 and including a photocatalytic material such that when exposed to ultraviolet rays the surface of the catheter is disinfected ¶0041.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781